American Regent, Inc. Issues Voluntary Nationwide Recall of One Lot of Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL Due to the Presence of Visible Particulate Matter
- Date
- Jul 24, 2026
- Company
- American Regent, Inc.
- Brand
- American Regent, Inc.
- Product
- Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL
- Reason
- Products were found to contain particulate matter
- Hazard
- Other
- Source
- FDA
How to identify the product
- July 24, 2026 – Shirley, NY, American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single dose vial to the consumer level.
- Papaverine Hydrochloride Injection, USP, is a clear, colorless pale-yellow solution and is available in a 2 mL single-dose vial containing 30 mg/mL
- Papaverine Hydrochloride Injection, USP Lot # 25202 was distributed nationwide in the United States beginning September 30, 2025.
- NDC, lot, expiration date and distribution dates can be found on the table below.
- Product Description: Papaverine Hydrochloride Injection, USP 60 mg/2 mL Single dose vial NDC: 0517-4002-25 Lot#: 25202 Expiration Date: 11/30/2026 Distribution Dates: 9/30/2025
- American Regent, Inc. is notifying its distributors and customers by letter and is arranging for return/replacement etc. of all recalled products.
Product photos are on the official FDA page.
Facts are taken from the official notice. If anything here differs from it, the official notice is correct.